Criteria for an ADLT:
(1) A service developed by a company.
(2) The service is only available at that company.
(3) The test involves one or more of the following:
(3a) the test is an analysis of multiple biomarkers with results combined in a unique algorithm to yield a single patient specific result.
(3b) the test is cleared or approved by the U.S. Food and Drug Administration (FDA)
(3c) the test meets criteria established by CMS
The biomarkers may consist of DNA, RNA or proteins.
where:
• Many such tests are patented but a patent does not appear to be a requirement.
• A single laboratory could offer several such tests.
• The number of biomarkers is not specified but 1 would be insufficient as written.
• The analyte cannot be other than DNA, RNA or protein as written.
